Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation in the Management of Neurological Sequelae After Traumatic Brain Injury
Overview
- Phase
- Phase 1
- Intervention
- autologous bone marrow-derived mononuclear cell transplantation
- Conditions
- Sequelae of Injuries of Head
- Sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Adverse events and serious adverse events
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow-derived mononuclear cell transplantation in the management of neurological sequelae after traumatic brain injury
Detailed Description
To evaluate the safety and efficacy of autologous bone marrow-derived mononuclear cell transplantation in 25 patients with neurological sequelae after traumatic brain injury compared with 25 patients in control group (no intervention) at the time points of baseline, 3rd month (D90), 6th month (D180), and 12th month (D360).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: from 20 to 50 years
- •Gender: either sex
- •Duration after Brain trauma: 6 - 12 months
- •Functional Independence Measure - FIM \< 69
- •Closed head injury
Exclusion Criteria
- •Neurologic impairment or neurological disease before the time of the accident.
- •Active infections
- •Tumours or failure of heart, lung, liver or kidney, respiratory distress syndrome
- •Anaemia, clotting disorder
- •Pregnancy
- •Alcoholic
- •Patient was unemployed or did not attend school before the accident.
- •Severe injuries: spinal cord injury, pelvic inflammation, cardiopulmonary
Arms & Interventions
Treatment (BM-MNC trasnplatation)
Autologous bone marrow-derived mononuclear cell will transplant at baseline, and the second transplantation will be performed 6 months after the first transplantation and combination with rehabilitation therapy
Intervention: autologous bone marrow-derived mononuclear cell transplantation
Treatment (BM-MNC trasnplatation)
Autologous bone marrow-derived mononuclear cell will transplant at baseline, and the second transplantation will be performed 6 months after the first transplantation and combination with rehabilitation therapy
Intervention: Rehabilitation therapy
Control group
rehabilitation therapy
Intervention: Rehabilitation therapy
Outcomes
Primary Outcomes
Adverse events and serious adverse events
Time Frame: up to the 12-month period following treatment
Incidence of the adverse events or serious adverse events after transplantation
Functional Independence Measure
Time Frame: up to the 12-month period following treatment
Functional Independence Measure assess and grade the functional status of patient
Extended Glasgow Outcome Scale
Time Frame: up to the 12-month period following treatment
Extended Glasgow Outcome Scale classifies global outcome in TBI survivors
Secondary Outcomes
- to monitor the functional metabolic changes in the brain of the patients(up to the 12 months after transplantation)
- Short Form 36(up to the 12-month period following treatment)